Comparison of Functional Outcome Between Bone Quadriceps Tendon (BQT) and Single-Bundle Hamstring Tendon (SBHT) Autograft in Arthroscopic-assissted Anterior Cruciate Ligament Reconstruction: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Changes (Improvement) of Rolimeter Measurement After Procedure
研究概览
简要总结
ACL rupture has a high morbidity in productive-age population. The increasing incidence and proper management has become a point of interest in the musculoskeletal sport injury. Choosing the best graft has become the main focus in searching for a better outcome regarding ACL reconstruction in these patient population. Currently, single bundle hamstring tendon (SBHT) autograft was preferred in Asian population compared to bone quadriceps tendon (BQT) autograft. However, there are some problems such as smaller size, as well as diameter, of SBHT. This study is focused on evaluation of the clinical outcome between BQT and SBHT in arthroscopic-assisted ACL reconstruction patients.
详细描述
In this prospective cohort study, 30 subjects were divided into 2 groups (BQT and SBHT). Sampling was taken between February 2016-2017 (1 year) in one orthopaedic center. The instruments used for evaluation are rolimeter and PRO questionnaires (IKDC, Tegner-Lysholm, and KOOS) with data mining between 1 month, 3 months, and 6 months post operation.
To obtain a valid and accountable research data, the investigators collected the information based on 2 parameters and then crosschecked the results.
After clinical data was obtained, the investigators translate the results into a statistical data using SPSS ver.24 and simplified the data for national registry and academic purposes.
According to previous studies, and research hypothesis, functional outcome of patient undergoing arthroscopic-assisted ACL reconstruction is better in BQT group compared to SBHT group, both in subjective and objective parameters given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral, total rupture of ACL
- •Procedure performed by the same surgeon
- •Age of subjects between 15-40 years old
排除标准
- •Multiligamentous injury
- •Bilateral ACL ruptures
- •Ligamentous laxity
- •Prior knee ligamentous surgery
研究组 & 干预措施
BQT Group
Procedure on this arm = bone quadriceps tendon reconstruction
干预措施: Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction (Procedure)
SBHT Group
Procedure on this arm = single-bundle hamstring tendon reconstruction
干预措施: Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction (Procedure)
结局指标
主要结局
Changes (Improvement) of Rolimeter Measurement After Procedure
时间窗: Measurement in 1 year after operation
1. Rolimeter measurement is the objective outcome expected in this study 2. This device was calibrated and tested prior to the usage in the study 3. Literature review --\> no significant difference between KT1000/2000 and rolimeter for measuring antero-posterior translation of the knee joint
Changes (Improvement) of PRO Questionnaire After Procedure
时间窗: PRO was taken in a period of 1 year after surgical procedure
1. We use three different PRO to make an accountable subjective outcome 2. No standard PRO questionnaire for ACL cases; we used three to be able to triangulate the mean subjective outcome 3. Rationale for using three PRO : these PROs were rapidly used in other similar studies around the world, had good and reliable results, and contains categoric and numeric data for statistical computation and interpretation
次要结局
未报告次要终点
研究者
Andri Maruli Tua Lubis
Head of Orthopaedic Sports and Arthroscopy Division, Principal Investigator
Indonesia University